Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02520921 |
| Other study ID # |
P141005 |
| Secondary ID |
2015-000947-18 |
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 13, 2016 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in
the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic
events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin
response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with
acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the
occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in
patients with a known risk factor.
Description:
Patients who show high persistent platelet reactivity under aspirin are increasingly becoming
an issue of clinical concern. Several studies have suggested that giving aspirin more
frequently is very effective for reducing aspirin high persistent platelet reactivity,
especially in diabetic patientsor in patients with a known risk factor. The aim of the study
is to evaluate low dose of aspirin twice a day (compared to once a day) for the reduction of
ischemic events in diabetic patients or in patients with a known risk factor, with acute
coronary syndrome.
Experimental Design:
A multicenter, randomised, parallel group comparing aspirin given twice a day compared to
once per day in diabetic patients, or in patients with a known risk factor for non-optimal
aspirin response (obesity, abdominal obesity or coronary event occurring with long-term
aspirin),with acute coronary syndrome.
Primary objective:
To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in
the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic
events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin
response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with
acute coronary syndrome.
Secondary objectives:
- To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg
in the evening) versus Aspirin Protect® 100 mg once per day on net clinical benefit
combining the ischemic and bleeding events in diabetic patients, or in patients with a
known risk factor for non-optimal aspirin response (obesity, abdominal obesity or
coronary event occurring with long-term aspirin),with acute coronary syndrome.
- To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg
in the evening) versus Aspirin Protect® 100 mg once per day on cardiac events in
diabetic patients, or in patients with a known risk factor for non-optimal aspirin
response (obesity, abdominal obesity or coronary event occurring with long-term
aspirin),with acute coronary syndrome.
- To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg
in the evening) versus Aspirin Protect® 100 mg once per day in each of individual
component of the main criterion.
- To confirm the safety of the innovative strategy (aspirin twice a day) concerning major
bleeding events.
Study enrollment:
Multicentric national study involving 42 centers in France The duration is expected to be 24
months of recruitment. Patients will be randomized during the index hospitalization for acute
coronary syndrome and before discharge between a conventional strategy of enteric coated
aspirin 100mg per day with the standard of care or a innovative strategy of enteric coated
aspirin 100mg morning and evening. Patients will be followed at one month, six months, one
year and 18 months
Statistical analysis:
The study will include 2574 patients. We hypothesized that at 18 months, there will be an
event rate of 22% for "death, MI, stroke, urgent revascularization, or acute arterial
thrombotic event in the group treated with aspirin and we expect a decrease of the primary
event of 20% (relative variation) using aspirin twice a day corresponding to an event rate of
17.6%.
A sample size of 1287 patients /group will allow an 80% power to detect this difference using
a log-rank test at a two-sided 5% significance level. The study will include 2574 diabetic
patients, or patients with a known risk factor for non-optimal aspirin response.
The primary analysis is based on the Intention To Treat population and the primary endpoint.
The primary analysis on the primary endpoint will be carried out using a log-rank test for
survival analysis. The 95% confidence interval of the hazard ratio will be presented. In
addition the survival status during 18 months follow-up will be described by showing
Kaplan-Meier curves.
Primary outcome according to pre-specified subgroups:
- Age: patients < 75 years or patient ≥75 years
- Gender: male or female
- Insulin vs no insulin treatment
- Type of acute coronary syndrome : STEMI vs NSTEMI
- Type of ADP inhibitor cotreatment
- Treatment strategy medical vs invasive (angioplasty or CABG surgery)
- Peripheral artery disease Yes/No
- GRACE score > or ≤140
- Left ventricular ejection fraction > or ≤ 40%
- Prior stroke Yes/No
- previous treatment with aspirin Yes/No
- initial HbA1C level > or ≤8%
- duration of diabetes > or ≤10 years
- Weight <60; 60-90; >90kg
- PPI use Yes/No
